Identity
- Trade Name
- St. Jude Medical™ FDA UDI
- Generic Name
- Heart valve prosthesis tester, single-use FDA UDI
- Device Name
- Mechanical Heart Valve Leaflet Tester FDA UDI
- Model / Reference
- LT100 FDA UDI
- Description
- Mechanical Heart Valve Leaflet Tester FDA UDI
Identifiers
- Catalog Number
- LT100 FDA UDI
- Primary DI / UDI-DI
- 05415067004772 FDA UDI
- FDA Product Code
- KDC FDA UDI
- GMDN Term
- Heart valve prosthesis tester, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heart valve prosthesis tester, single-use
St. Jude Medical™ by St. Jude Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heart valve prosthesis tester, single-use.
- Leaflet Tester — Corcym Canada Corp · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 5c8ba0fe-15c2-4a64-ae7c-2e7d87db2481 35 fields · synced Jun 1, 2026